Name: Predicase
Price: 199 USD

K-number	K212410
Device name	VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium
Applicant	Shenzhen Vitavitro Biotech Co., Ltd.
Product code	MQL
Device class	Class II
Decision date	Feb 1, 2022
Decision	Substantially Equivalent
Regulation	884.6180

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Source

View the full FDA submission: accessdata.fda.gov

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VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium

Everything you need for a 510(k) submission. Nothing you don't.